HIV Testing Strategies in the Perinatal Setting

This study has been completed.

Sponsor:

Collaborator:

Pfizer

Information provided by:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT00503308

First received: July 16, 2007

Last updated: June 7, 2011

Last verified: June 2011

Results First Received: September 24, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Health Services Research
Conditions:	HIV Infections Pregnancy Related
Intervention:	Procedure: Abbreviated HIV test counseling

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A randomized-controlled, non-inferiority trial was conducted from October 2006 through February 2008 at San Francisco General Hospital (SFGH), the public teaching hospital of the City and County of San Francisco.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 278 English- and Spanish-speaking pregnant women were randomized to receive either abbreviated or standard nurse-performed HIV test counseling at the initial prenatal visit.

Reporting Groups

	Description
Standard Consenting Intervention	The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
Abbreviated Consenting Intervention	The intervention arm used a 2-sentence script which lasted approximately 30 seconds.

Participant Flow: Overall Study

	Standard Consenting Intervention	Abbreviated Consenting Intervention
STARTED	146	135
COMPLETED	144	134
NOT COMPLETED	2	1
Protocol Violation	2	1

Baseline Characteristics

Reporting Groups

	Description
Standard Consenting Intervention	The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
Abbreviated Consenting Intervention	The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
Total	Total of all reporting groups

Baseline Measures

	Standard Consenting Intervention	Abbreviated Consenting Intervention	Total
Number of Participants [units: participants]	146	135	281
Age [units: participants]
<=18 years	8	5	13
Between 18 and 65 years	138	130	268
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	26.99 ± 6.1	26.39 ± 5.3	26.7 ± 5.73
Gender [units: participants]
Female	146	135	281
Male	0	0	0
Region of Enrollment [units: participants]
United States	146	135	281

Outcome Measures

1. Primary:

Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale) [ Time Frame: same day as HIV test counseling (cross-sectional study) ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information